A Phase 2 interventional study of Normal Saline 0.9% Infusion Solution Bag and 1.5% Glycine only in Hypertension, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-06.
Sponsored by Assiut University · Phase 2, Interventional, and Prevention
Hysteroscopy is a minimally invasive gynaecological procedure in which an endoscopic optical lens is inserted through the cervix into the endometrial cavity to assists in the diagnosis of a vast number of uterine pathologies Historically, urologists used the resectoscope to perform a transurethral prostatectomy. This instrument was later modified to accommodate gynaecological applications. Operative hysteroscopy became popular after improvements in endoscopic technology and instruments in the 1970s and after the introduction of fluid distension media in the 1980s (1). During the past 2 decades, hysteroscopy has been increasingly used for operative procedures
Operative hysteroscopy has become a standard surgical treatment for abnormal uterine bleeding unresponsive to conservative medical management since it was shown as a safe and effective alternative to hysterectomy.(2,3) Monopolar resectoscope necessitates an irrigating fluid that should be a non-conductive and salt free solution such as glycine 1.5% or sorbitol 3%.(4) Physiologic irrigating fluids (e.g. saline 0.9%) are contraindicated with these instruments since electric current generated by any monopolar electro surgical unit is preferentially conducted through low impedance fluid rather than through tissue and consequently it's difficult to initiate cutting and impossible to create significant tissue coagulation with these devices The clinical drawback of non-conductive irrigating solution (e.g. glycine 1.5%) is the risk of excessive fluid absorption leading to symptomatic dilutional hyponatremia and for hypotonic solutions, hypo-osmolarity and secondary cerebral oedema as Glycine is metabolized to carbon dioxide, water and ammonia, and may lead to intra-cellular over hydration and neurotoxicity which is clinically reflected as hypoxemia, agitation, nausea and hypertension.(5).Although rare, irreversible neurologic damage and death have been reported after excessive absorption of salt free irrigating solutions during routine operative hysteroscopy(6)Theoretically, distension with 0.9% saline as a distension medium avoids most of the above mentioned risks associated with hyper absorption of non electrolytic distension media(7) However, there is no doubt that excessive absorption of normal saline can be fatal(8).
Recently , it has been suggested that the type of anesthesia could modify fluid absorption(9). General anaesthesia has been associated with less Glycine absorption than epidural anaesthesia: the latter being associated with systemic vasodilatation(9).
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Exclusion Criteria:
0.9% saline distension media is used as long as diathermy is not in use
Drug: Normal Saline 0.9% Infusion Solution Bag
1.5% GLYCINE DURING OPERATIVE HYSTEROSCOPY as long as diathermy is in use
Drug: 1.5% Glycine only
0.9% saline as distension medium as long as diathermy is not in use
1.5% Glycine alone during hysteroscopy as long as diathermy is in use
Change from Baseline Systolic Blood Pressure
Non-invasive blood pressure measurement by using sphygmomanometer cuff
Time frame: data will be collected over 24 hours from the beginning of the procedure
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Assiut University